ASGE guideline on the management of cholangitis

Cholangitis is a GI emergency requiring prompt recognition and treatment. The purpose of this document from the American Society for Gastrointestinal Endoscopy’s (ASGE) Standards Practice Committee to provide an evidence-based approach management cholangitis. This addresses modality drainage (endoscopic vs percutaneous), timing intervention (<48 hours >48 hours), extent initial (comprehensive therapy decompression alone). Grading Recommendations, Assessment, Development, Evaluation methodology was used formulate recommendations on these topics. ASGE suggests endoscopic rather than percutaneous biliary within 48 hours. Additionally, panel that sphincterotomy stone removal be combined with alone, unless patients are too unstable tolerate more extensive Patients cholangitis may respond medical including antibiotics. However, tree necessary in most cases. Mortality associated surgical ranges 10% 40% has been correlated disease severity.1Boey J.H. Way L.W. Acute cholangitis.Ann Surg. 1980; 191: 264-270Crossref PubMed Scopus (209) Google Scholar, 2Csendes A. Diaz J.C. Burdiles P. et al.Risk factors classification acute suppurative cholangitis.Br J 1992; 79: 655-658Crossref (79) 3Thompson Jr., J.E. Tompkins R.K. Longmire W.P. Factors 1982; 195: 137-145Crossref (100) Scholar Randomized comparative trials indicate ERCP achieves markedly less morbidity mortality compared surgery, regardless clinical severity.4Lai E.C. Mok F.P. Tan E.S. al.Endoscopic severe cholangitis.N Engl Med. 326: 1582-1586Crossref (460) Percutaneous transhepatic (PTBD) represents alternative option defined role. relative onset whether duct clearance should attempted during remain controversial. aim guideline treatment based systematic review synthesis literature using (GRADE) methodology. GRADE adopted by Endoscopy as system rate quality evidence strength rigorous transparent manner.5Wani S. Sultan Qumseya B. al.The ASGE'S vision developing practice guidelines: path forward.Gastrointest Endosc. 2018; 87: 932-933Abstract Full Text PDF (7) following questions:1.In cholangitis, or favored method does it vary severity?2.In early performed at (≤48 hours) after admission improve outcome undergoing hours?3.In what role (sphincterotomy, lithotripsy, clearance) (stent nasobiliary tube) versus alone ERCP? A working group (SOP) drafted document. relevant questions outcomes were developed SOP committee approved Governing Board. derive 1 3, systematically best evidence, develop (Table 1). full all face-to-face meeting March 7, 2020.Table 1Summary recommendation derived methodologyStatementStrength recommendationQuality evidence1.For we suggest over drainage.ConditionalVery low2.For performance ≤48 h h.ConditionalVery low3.For other maneuvers such stent alone.ConditionalLow Open table new tab included 3 content experts expertise meta-analysis (J.L.B., N.C.T., S.W.), expert independent (B.J.E.), methodologist (B.J.Q.), hepatobiliary surgeon (E.P.C.), interventional radiologist (A.R.), patient representative (P.M.), members Committee. All asked disclose conflicts interests policy (https://www.asge.org/forms/conflict-of-interest-disclosure https://www.asge.org/docs/default-source/about-asge/mission-andgovernance/asge-conflict-of-interest-and-disclosure-policy.pdf). Panel who received funding any technologies companies population, intervention, comparator, (PICOs) declare before discussion did not vote final addressing specific PICO question. amenable 2). For each question, identified population (P), (I), comparator (C), interest (O). Patient critical successful resolution adverse events.Table 2List addressedPopulationInterventionComparatorOutcomesRating1.Cholangitis∗Overall stratified severity.ERCP decompressionPercutaneous cholangiography drainage1)Successful decompressionCritical2)MortalityCritical3)Length hospitalizationImportant4)Adverse events (pancreatitis, bile leak, hemorrhage, perforation)Critical2.Cholangitis∗Overall hERCP > h1)MortalityCritical2)Length hospitalizationImportant3)Organ failureCritical4)30-Day organ failureCritical3.Cholangitis∗Overall sphincterotomy, removal, decompressionERCP alone1)Successful decompressionCritical2)Adverse eventsCritical3)Repeat procedures (ERCP, cholangiography, surgery)Critical4)Length hospitalizationImportant∗ Overall severity. existing reviews assessed, and, if unavailable, de novo address topic. health sciences librarian (H.S.) search strategy searched databases July 15, 2019 February 28, 3. (coverage 1946 present), Embase Classic 1947 Cochrane Library 1898 Web Science 1900 present). No filters applied date, study type, language, limit. combination subject headings (when available) key words concepts drainage, drainage. In effort capture unpublished studies, conducted searches ClinicalTrials.gov. Because database constraints lack replicability, only first 200 citations collected. Cross-referencing (snowballing) forward articles fulfilling inclusion criteria pertinent Science. 2 described Iqbal al.,6Iqbal U. Khara H.S. Hu Y. al.Emergent urgent cholangitis: meta-analysis.Gastrointest 2020; 91: 753-760Abstract (18) which contains methods See Supplementary Tables (available online www.giejournal.org) strategies details. Citations imported into EndNote x9.2 (Clarivate Analytics, Philadelphia, Pa, USA), duplicates removed Bramer method, remainder uploaded Covidence (Melbourne, Australia) screening.7Bramer W.M. Giustini D. Jonge G.B. al.De-duplication results EndNote.J Med Libr Assoc. 2016; 104: 240-243Crossref (334) Two reviewers data extraction. Pooled effects calculated random models. summary statistics overall diagnostic odds ratios (OR) (PICOs 1-3), standardized mean differences 3), (PICO Heterogeneity quantified I2 statistic assessed sensitivity analyses. Indirect comparisons perform subgroup analyses severity when direct available. confidence estimated determined domains: bias individual imprecision, inconsistency, indirectness, publication bias. Certainty categorized 4 levels: high, moderate, low, very low 3). profiles generated GRADEpro/GDT applications (https://gdt.guidelinedevelopment.org/app).Table 3GRADE categories evidenceGRADE evidenceMeaningInterpretationHighWe confident true effect lies close estimate effect.Further research unlikely change our effect.ModerateWe moderately effect; likely effect, but there possibility substantially different.Further have impact estimate.LowOur limited; different estimate.Very lowWe little effect.Any uncertain.GRADE, Evaluation. GRADE, certainty balance benefit harm, values preferences, cost-effectiveness, resource utilization. wording recommendation, particular direction strength, consensus among members. used, strong conditional. word “recommend” “suggest” conditional recommendations. Suggested interpretation patients, clinicians, policymakers provided Table 4.Table 4Interpretation definitions frameworkImplications forStrong recommendationConditional recommendationPatientsMost individuals situation would want recommended course action small proportion not.Most suggested action, many not.CliniciansMost receive intervention. Formal decision aids needed help make decisions consistent their preferences.Recognize choices will appropriate you must arrive his her preferences. Decision useful helping preferences.PolicymakersThe can situations. Compliance according could criterion indicator.Policymaking require substantial debate involvement various stakeholders. Limited studies preferences regards indicated PTBD given consistently shorter hospitalization result discomfort external catheter.8Kumar R. Kwek M. Outcomes intensive care unit (ICU) retrograde cholangiopancreatography (ERCP) [abstract].Gastrointest 83: AB247-AB248Abstract 9Park C.S. Jeong Kim K.B. al.Urgent reduces hospital stay elderly patients.Hepatobil Pancreat Dis Int. 15: 619-625Crossref (12) 10Sugiyama Atomi Treatment due choledocholithiasis younger patients.Arch 1997; 132: 1129-1133Crossref (88) <48 also formally studied. advantage (vs alone) deemed desirable representative. limited decrease required number alone.11Yamamiya Kitamura K. Ishii al.Feasibility common cholangitis.World Clin Cases. 2017; 5: 280-285Crossref Using Nationwide Inpatient Sample (NIS) 248,942 McNabb-Baltar al12McNabb-Baltar J. Trinh Q.D. Barkun A.N. Biliary temporal trends admitted national audit.Can Gastroenterol. 2013; 27: 513-518Crossref (8) demonstrated 54.7% managed accrued high charges (>75th percentile) 32.7% treated via ERCP. length PTBD, potentially translates cost savings.8Kumar Comparative report analysis.6Iqbal Nevertheless, 77,323 NIS database, Parikh al13Parikh M.P. Wadhwa V. Thota P.N. al.Outcomes secondary choledocholithiasis.J 52: e97-e102Crossref (14) significantly costly ($48,627 [95% interval {CI}, 47,058-50,196]) 24 ($31,108 CI, 29,987-32.230]), lowest <24 ($25,836 24,867-26,805]). Mulki al14Mulki Shah Qayed E. Early late nationwide analysis.World Gastrointest 2019; 11: 41-53Crossref 2014 National Readmissions Database show costs ($16,939 $21,459, respectively). Similarly, tertiary center, Khashab al15Khashab M.A. Tariq al.Delayed unsuccessful worse cholangitis.Clin Gastroenterol Hepatol. 2012; 10: 1157-1161Abstract (73) reported considerable (>90th (odds ratio [OR], 11.3; 95% 1.3-98) >72 ≤72 admission. Interestingly, weekend reduce ($71,662 70,499-72,605] $71,469 69,627-73,312] weekday ERCP) despite delay days.16Inamdar Sejpal D.V. Ullah al.Weekend vs. admissions ERCP: comparison cohort.Am 111: 405-410Crossref (22) cost-effectiveness assessing lacking need addressed future studies. Shorter (ERCP removal) meta-analysis, reduced savings, although financial considerations available source articles. Yamamiya al11Yamamiya median $726 (interquartile range, 579-1028) $988 868-1033) alone. summarized Figure 1. Question 1: PTBD? Recommendation PTBD. (Conditional Very evidence). important question mortality, decompression, hospitalization, events. profile presented 5. We compare setting inception through 15,110 (Supplementary Eighty-nine met criteria, methods.Table 5Evidence cholangitisCertainty assessmentNo. patientsEffectCertaintyImportanceNo. studiesStudy designRisk biasInconsistencyIndirectnessImprecisionOther considerationsERCPPTBDRelative (95% interval)Absolute interval)Drainage success6Observational studiesNot seriousSerious∗Low events.,†High I2.Not seriousNot seriousNone699/745 (93.8%)208/244 (85.2%)OR, 1.75 (.26-12.03)58 per 1000 (from 252 fewer 133 more)⊕◯◯◯VERY LOWCRITICALOverall events2Observational seriousSeriousNone6/93 (6.5%)13/73 (17.8%)OR, .28 (.04-2.05)121 169 129 LOWCRITICAL30-day mortality3Observational events.None2/93 (2.2%)4/73 (5.5%)OR, .25 (.06-1.10)41 51 5 LOWCRITICALMean stay3Observational events.None38696—Mean difference, days lower (2.05 1.46 lower)⊕◯◯◯VERY LOWCRITICALPTBD, drainage; OR, ratio; —, insufficient available.∗ Low events.† High I2. 6 observational trials. These 745 internal tube 244 underwent Among 12 had previously undergone ERCP, those 10 failed Based model, no difference rates between (OR, .3; .1-1.1; = 0) Fig. 1, www.giejournal.org). 1.8; .3-12), significant heterogeneity observed (I2 83.1%) There modalities 0-2.1; 46.5%), As stay, (11.7 5.5-17.8], 99%) (23.1 8-38.4], 98.8%); 1.8 1.5- 2.1; 94%) (Fig. Given data, analyzed To investigate variable conduct analysis, indirect 89 percutaneous, endoscopic, both modalities. 9100 887 successfully (97% 96-98%]; 83) (94% 88-98]; 85%) 4, differ populations specified nonsevere 5, analysis noncomparative trials, higher event 7-14; 17%) 5% 4-7; 81%) largely driven increased bleeding 5). limited. Although comparable modalities, appeared (14% 1-35]; (4% 2-6]; 0). tended greater (23.2 8-38.4]; 75%) (10.4 9-11.8]; 99%), reach statistical significance. Hospitalization issues bias, particularly related degree selection comparability approaches Newcastle-Ottawa tool 6, rated down inconsistency appear serious indirectness. discussions regarding undesirable treatments, implications utilization experience. achieved success, stay. Unfavorable aspects bleeding, comparison. Postprocedure pancreatitis major disadvantage conclude occurs frequently Overall, judged regard subanalyses Studies life lacking, advocate (P.M.) expressed preference citing value length, favorable profile, negative drains life. Endoscopic primary cholangitis.4Lai Scholar,12McNabb-Baltar same goal, they involve technical profiles. bacteremia, abscess formation, whereas dominant pancreatitis.17Chen M.F. Jan Y.Y. Lee T.Y. cholangitis.Int 1987; 72: 131-133PubMed Scholar,18Lois J.F. Gomes A.S. Grace P.A. al.Risks cholangitis.AJR Am Roentgenol. 148: 367-371Crossref (27) found success comparable. revealed periprocedure hemorrhage. events, assessment values. correlates nearly quarter million demonstrates 1998 2009 use (54.2%-57%) (5.0% 4.6%) surgery (8.2% 2.8%).12McNabb-Baltar (3.3% 8.9%).12McNabb-Baltar Schola